# K091556: Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 21, 2010 after 359 days
- Product code: MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031208 (2003). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031208: Reaads Igm Anti-B2GPI Test Kit, Model 038-001, Corgenix, Inc. (2003) Summary page 1.

## Most influential descendants
- K223093: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (2024), 0 descendants of its own
- K221359: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (2023), 0 descendants of its own
- K130528: Bioplex 2200 Apls Igm (2013), 0 descendants of its own

## Indications for use
HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-I (anti-β2 GPI) IgG antibodies in human citrated plasma and serum on the ACL AcuStar™, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgG Controls: For the quality control of the Anti-β2 Glycoprotein-I IgG assay performed on the ACL AcuStar. HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-I (anti-β2 GPI) IgM antibodies in human citrated plasma and serum on the ACL AcuStar™ as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgM Controls: For the quality control of the Anti-β2 Glycoprotein-I IgM assay performed on the ACL AcuStar.

Source page: https://510kreport.com/device/K091556
Methodology: https://510kreport.com/methodology